Stanley Specialty Pharmacy Compounding and Wellness Center

CLOSEOUT LETTER Stanley Specialty Pharmacy Compounding and Wellness Center MARCS-CMS 557711 — February 08, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Douglas Yoch Recipient Title Pharmacist-In-Charge Stanley Specialty Pharmacy Compounding and Wellness Center 3120 Latrobe Dr. Ste. 200 Charlotte , NC 28211-2185 United States Issuing Office: Drug Product/Adulterated United States Mr. Yoch: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case # 557711; dated July 24, 2018]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ John W. Diehl, M.S Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II U.S. Content current as of: 02/08/2022 Regulated Product(s) Drugs